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A Phase II Study of PS-341 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter, and Renal Pelvis)

Phase 2
18 Years
Not Enrolling
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

Thank you

Trial Information

A Phase II Study of PS-341 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter, and Renal Pelvis)


- Determine the response rate and duration of response in patients with advanced or
metastatic transitional cell cancer of the bladder, renal pelvis, or ureter when
treated with bortezomib.

- Determine the 1-year, median, and overall survival rate of patients treated with this

- Determine the stable disease rate and duration and time to progression in patients
treated with this drug.

- Determine the toxicity of this drug in these patients.

- Correlate baseline and post-treatment levels of NF-kappaB and HIF-1 alpha in tumor
biopsies with clinical outcome in patients treated with this drug.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity. Patients in
complete remission (CR) may receive up to 2 courses after confirmation of CR.

Patients are followed within 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within
approximately 6.6-17.5 months.

Inclusion Criteria


- Histologically or cytologically confirmed transitional cell cancer of the urothelium,
including the bladder, renal pelvis, or ureter

- Advanced or metastatic disease

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- The following are not considered measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- No known brain metastases



- 18 and over

Performance status

- ECOG 0-1 OR

- Karnofsky 80-100%

Life expectancy

- More than 3 months


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- AST/ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases are


- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 45 mL/min


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able and willing to undergo biopsy of tumor lesions

- No other primary cancer requiring treatment within the past 3 years except curatively
treated nonmelanoma skin cancer or carcinoma in situ of the cervix

- No grade 1 or greater peripheral neuropathy

- No ongoing or active infection

- No other concurrent uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

- Not specified


- No more than 2 prior chemotherapy regimen for metastatic disease

- Prior neoadjuvant or adjuvant therapy allowed provided it was completed more
than 12 months prior to study entry

- Patients who relapse within 12 months after completion of neoadjuvant or
adjuvant therapy are allowed provided they did not receive chemotherapy for
recurrent disease

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

- Prior chemotherapy as a radiosensitizer is allowed* NOTE: *May be administered
concurrently with radiotherapy; may be in addition to a single line of therapy for
locally advanced or metastatic disease

Endocrine therapy

- Not specified


- See Chemotherapy

- More than 4 weeks since prior myelotoxic radiotherapy (more than 3,000 cGy to fields
including substantial bone marrow) and recovered

- No concurrent radiotherapy


- At least 4 weeks since prior surgery for cancer of the urothelium (except nephrostomy
tubes and ureteral stents)


- At least 4 weeks since any prior therapy and recovered

- No other concurrent investigational or commercial agents or therapies intended to
treat the malignancy

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response by RECIST criteria every 6 weeks

Safety Issue:


Principal Investigator

Eric Winquist, MD

Investigator Role:

Study Chair

Investigator Affiliation:

London Regional Cancer Program at London Health Sciences Centre


United States: Federal Government

Study ID:




Start Date:

September 2003

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • recurrent bladder cancer
  • stage IV bladder cancer
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • recurrent transitional cell cancer of the renal pelvis and ureter
  • regional transitional cell cancer of the renal pelvis and ureter
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms



Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Evanston Evanston, Illinois  60201
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey, Illinois  60426
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
Oncology Care Associates, P.L.L.C. Saint Joseph, Michigan  49085